Kornimate/medical-research-clean huggingface dataset:
[18f]f-arag pet imaging to visualize tumor infiltrating t-cell activation in non-small cell lung cancer.

Conditions: Non-Small Cell Lung Cancer

Summary: \[18f\]f-arag is a promising tracer to image activated t-cells with positron emission tomography (pet). the aim of the attain trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (trt) variability and to correlate the tumor tracer uptake with the pathological assessment.

the efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (tme) could be characterized more accurately. positron emission tomography (pet) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the tme. imaging t-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating t-cells and also provide information on its activation. a promising tracer to image activated t-cells is \[18f\]f-arag. based on the hypothesis that \[18f\]f-arag will accumulate in activated t-cells, it is expected that \[18f\]f-arag and pet will enable to (reproducibly) identify tumors and tumor areas with high concentrations of tumor infiltrating activated t-cells on pathological assessment. in the attain trial this \[18f\]f-arag uptake in tumor lesions and healthy organs is explored by full kinetic modelling.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed nsclc, a histological biopsy is mandatory. 2. patients that are resectable upfront as per multidisciplinary tumor board evaluation. 3. be willing and able to provide written informed consent for the trial. 4. be above 18 years of age on day of signing informed consent. 5. have a performance status of 0-1 on the ecog performance scale at screening. exclusion criteria: 1. subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of screening. inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 2. psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 3. patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last \[18f\]f-arag pet scan.

Keywords: positron emission tomography [18f]f-arag t-lymphocytes kinetic modelling reproducibility of results
the effects of different ways of dressing central line associated bloodstream infections

Conditions: Central Line-associated Bloodstream Infection (CLABSI)

Summary: the goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.

the study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern taiwan. the investigators used block randomization to assign patients to the study group or control group. in study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. the investigators defined the infection outcome according to culture results, and the guidelines by infectious diseases society of america and centers for disease control and prevention, usa. analysis was done by spss version 23. the investigators used percentage and average to study characteristics of participants. the investigators used chi-square or fisher's exact test and poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. the investigators used kaplan-meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. the investigators used logistic regression model to analyze factors associated with development of bloodstream infections.

Eligibility criteria:
inclusion criteria: * adults older than 20 years old * patients with central venous catheters * agree to participate in this study, and fill out the study consent exclusion criteria: * picc patients placed * patients with bloodstream infection * patients with immunocompromised patients (such as hiv, aids, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)

Keywords: crbsi clabsi
a clinical trial assessing safety and efficacy of bzl101 for metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the investigators' proposed phase 2 clinical trial will be an open-label, non-randomized study among 80 women with metastatic breast cancer. the study treatment period will be up to twelve months and enrollment will be open at 10-15 clinical sites in the united states. in this phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone receptor negative tumors will be enrolled and treated with bzl101 20 grams/day (10 grams bid). hormone receptor positive will be defined as estrogen receptor (er)+ and progesterone receptor (pr)+, er+ and pr-, or er- and pr+. hormone receptor negative will be defined as er- and pr-.


Eligibility criteria:
inclusion criteria: 1. women 18 years or older. 2. histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer. 3. clinical evidence of metastatic (stage iv) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings. 4. availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (status on the most recent biopsy where er/pr status was documented will be used to determine hormone receptor status for stratification). 5. at least one measurable disease site defined by recist criteria, with measurement made within 30 days of beginning study therapy. (non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. for lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation). 6. no more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (participants may have received any number of exogenous hormone therapies for stage iv disease and/or adjuvant therapy). 7. life expectancy of \>12 weeks. 8. eastern cooperative oncology group performance status \<2. 9. women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. acceptable methods of contraception are as follows: 1. intrauterine device (iud) 2. hormonal birth control 3. tubal ligation 4. partner's vasectomy 5. latex condom 6. diaphragm 7. cervical cap 10. adequate organ and marrow function measured within 14 days of study treatment as defined below: absolute neutrophil count \>1,500 cells/mm3 platelets \>100,000 cells/mm3 hemoglobin \>10 g/dl total bilirubin \ 60 ml/min/1.73 m2 for participants with serum creatinine levels above institutional normal. exclusion criteria: -
clinical efficacy of changing the interstim® parameters in patients with interstitial cystitis/painful bladder syndrome

Conditions: Painful Bladder Syndrome; Interstitial Cystitis; Pelvic Floor; Insufficiency; Bowel Dysfunction; Sexual Dysfunction; Pelvic Floor; Incompetency

Summary: purpose: 1. to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (snm) in patients with interstitial cystitis /painful bladder syndrome (ic/pbs) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard). 2. the evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with ic/pbs, such as female sexual dysfunction (fsd), bowel dysfunction, high tone pelvic floor dysfunction (htpfd, painful spasm of the pelvic floor muscles), vulvodynia (pain at the opening of the vagina).

purpose: 1. primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (snm) in patients with interstitial cystitis /painful bladder syndrome (ic/pbs) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard). 2. secondary: the evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with ic/pbs, such as female sexual dysfunction (fsd), bowel dysfunction, high tone pelvic floor dysfunction (htpfd, painful spasm of the pelvic floor muscles), vulvodynia (pain at the opening of the vagina).

Eligibility criteria:
inclusion criteria: * female with diagnosis of ic/pbs with implanted ipg interstim. * scores \> 8 on the interstitial cystitis symptom index questionnaire (icsi) and \> 8 on the interstitial cystitis problem index questionnaire (icpi). * signed informed consent. exclusion criteria: * progressive neurologic disease or peripheral neuropathy. * history of bladder surgery. * subjects implanted with other neuromodulation device. * current or planning pregnancy; breastfeeding. * subjects who are not deemed able to fill questionnaires * mental illness or mentally unstable patients

Keywords: painful bladder syndrome interstitial cystitis pelvic floor dysfunction fecal incontinence constipation sexual dysfunction dyspareunia vulvodynia
rheumatoid arthritis medication adherence

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a public health issue because of its frequency, its functional consequences, the risk of morbidity and mortality and the costs incurred. a collaborative multiprofessional intervention initiated during hospitalization and continued after hospital discharge (ambulatory care ) would improve medication adherence in ra and therefore the health status of patients. main objective: to compare, 12 months after the index hospitalization or consultation, the impact of pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician) on medication adherence to disease-modifying treatments of patients with ra compared to usual care without pharmaceutical care and specific multi-professional collaboration. medication adherence to disease-modifying treatments will be assessed by the rate of coverage of disease-modifying treatments (or medication possession ratio (mpr)). methodology: interventional, multicenter, controlled, randomized, open label study, comparing in parallel 2 groups of patients with rheumatoid arthritis initially hospitalized in a rheumatology department (pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician), initiated in the hospital and continued after hospital discharge (ambulatory care) vs traditional follow-up.


Eligibility criteria:
inclusion criteria: * patient with diagnosed rheumatoid arthritis (ra), * patient, male or female, aged 18 or over, * patient hospitalized or coming for a consultation in a rheumatology department, and returned home at hospital discharge * patient having dmards for ra (continuation or initiation) comprising at least methotrexate and/or a tsdmard (targeted synthetic dmard, jak inhibitor) and/or subcutaneous bdmard (biologic dmard), * autonomous patient in the management of his drug treatment, * patient understanding and speaking french, * patient affiliated to the french general national health insurance or similar, * patient having given his free, informed and signed consent. exclusion criteria: * patient whose usual pharmacy already has or has had a patient included in the intervention group in the study, * patient whose regular pharmacy is currently treating another patient. * patient with obvious significant cognitive or psychiatric disorders incompatible with the study (according to the judgment of the investigator), * patient whose management of his drug treatment at home is carried out exclusively by a carer, * patient participating in another research that may interfere (investigator's judgement) with the results of the present study, * adult patient protected under the terms of the law (public health code), * patient not fit to carry out the follow-up, according to the judgment of the investigator, * pregnant or breastfeeding women.

Keywords: medication adherence rheumatoid arthritis pharmaceutical care
bioimpedance spectroscopy for the differential diagnosis of hyponatremia

Conditions: Hyponatremia

Summary: we aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia

* up to now, "hyponatremia" differentially diagnosed by physical examination, plasma and urine osmolalities, echocardiography and biochemical measurements. * the purpose of this study is to determine whether bioimpedance spectroscopy can be used for the detection of hypovolemia and hypervolemia for the differential diagnosis of hyponatremia.

Eligibility criteria:
inclusion criteria: * willing to participate in the study with written informed consent * older than 18-years exclusion criteria: * the presence of pacemaker or defibrillator * artificial joints, pin or amputation * pregnancy or lactating.

Keywords: bioimpedance spectroscopy hypervolemia hypovolemia
tolerability, safety and efficacy of flexibly dosed paliperidone er in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (er) in patients with schizophrenia from argentina and colombia that previously failed treatment with other antipsychotic agents.

this is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. throughout the study flexible dosing of paliperidone er in a range of 3 to 12 mg/day may be used. flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. patients will receive 3, 6, 9 or 12 mg of paliperidone er once daily for 6 months. the tablets will be taken orally. adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.

Eligibility criteria:
inclusion criteria: * patient meets the criteria for schizophrenia * patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication * patient is healthy on the basis of a physical examination and vital signs at screening * women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study exclusion criteria: * patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months * patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities * patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome * patients judged to be at high risk for adverse events, violence, or self-harm * patients with known hypersensitivity to paliperidone er or to risperidone * patients with a current use or known history (over the past 6 months) of substance dependence

Keywords: schizophrenia paliperidone extended-release (er) antipsychotic agents
a clinical study of enlicitide decanoate in people with liver function problems (mk-0616-030)

Conditions: Hepatic Insufficiency; Hepatic Impairment

Summary: researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (ldl-c) in a person's blood. enlicitide decanoate will be called "enlicitide" from this point forward, the purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or pk study). researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (hi- meaning the liver does not work properly) and people who are in good health. this study will have 2 parts. in part 1, enlicitide will be given to people with moderate hi and people who are in good health. after part 1, researchers may decide to include people who have mild hi and compare what happens to enlicitide in the body with people who are in good health.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: all participants: * has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study * has body mass index (bmi) ≥ 18.0 and ≤ 40.0 kg/m2 participants with moderate or mild hi: * diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause. * is generally in good health with the exception of hi. healthy control participants: * medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles exclusion criteria: the main exclusion criteria include but are not limited to the following: all participants: * history of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery. * history of cancer * consumes greater than 3 servings of alcoholic beverages per day. * is on statin background therapy. participants with moderate or mild hi: * severe complications of liver disease within 3 months of entering the study.
lower urinary tract symptoms after intravesical therapy

Conditions: Chemotherapy Effect; Chemotherapeutic Toxicity; Lower Urinary Tract Symptoms; Overactive Bladder

Summary: with this prospective, observational study, we would like to investigate the effect of instillation therapy using bcg or mitomycin c on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. the study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin c or bcg.


Eligibility criteria:
inclusion criteria: * urinary bladder carcinoma requiring instillation therapy * complete resection of the tumor * no intravesical chemotherapy in the last 3 months exclusion criteria: * patients who are unable to complete the questionnaires * patients who are not willing to participate * patients with contraindications for instillation therapy (allergic reactions, immunosuppression)
comparison between dexamethasone and ibuprofen on pain prevention and control following surgical implant placement

Conditions: Pain Measurement

Summary: background and aim: postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. this study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement. methods: for this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. the groups received three different protocols 1 hour before surgery: 1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); 2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or 3. placebo. rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.


Eligibility criteria:
inclusion criteria: * informed consent for the described procedure * surgical placement of a single endosteal implant * age of at least 18 years exclusion criteria: * the need for bone grafting or sinus lift for implant placement * pregnant and lactating women * metabolic disorders * immunocompromised status * hemophilia or bleeding disorders * drug or alcohol abuse * treatment with steroids in the previous 6 months * history of radiation therapy in the head and neck * psychiatric disorders * inability to understand the procedure described in the questionnaire
pilot study on sleep management for us veterans

Conditions: Insomnia

Summary: the aim of the proposed pilot study is to scientifically evaluate the use of mind-body bridging program (mbbp) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the primary care clinic at the veterans administration salt lake city health care system (vaslchcs).

participants will be randomly assigned to either mbbp or a treatment as usual sleep hygiene (sh) group. the interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). the sleep quality assessment questionnaire will be additionally completed after the first session (week 1).

Eligibility criteria:
inclusion criteria: 1. selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. because we are also interested in the effects of mbbp on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. thus our inclusion criteria will be broader than those based on dsm-iv for primary insomnia. 2. on the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see study procedure). in addition, they must also be able to attend the second session the following week. exclusion criteria: 1. the patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.

Keywords: sleep problems awareness training program mind body bridging